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Published on: February 26, 2013
Relationship between the Renal Function and Adverse Clinical Events in Patients with Atrial Fibrillation: A Japanese
Yasuhumi Yuzawa1, Keiichiro Kuronuma2, Yasuo Okumura3
1Department of Cardiology, Nihon University Hospital, Tokyo 101-8309, Japan.
Insights
In Japanese patients with atrial fibrillation (AF) and chronic kidney disease (CKD), moderate-severe CKD increased adverse events. Direct oral anticoagulants (DOACs) and warfarin showed similar safety and effectiveness across renal function levels.
Area of Science:
- Cardiology
- Nephrology
- Pharmacology
Background:
- Atrial fibrillation (AF) and chronic kidney disease (CKD) frequently coexist.
- Real-world data on direct oral anticoagulants (DOACs) in Japanese patients with AF and CKD are limited.
- Investigating the impact of renal function on adverse events and comparing DOACs with warfarin is crucial.
Purpose of the Study:
- To assess the association between baseline renal function and adverse clinical events in Japanese AF patients.
- To compare the risk of adverse events between DOACs and warfarin across different renal function levels.
Main Methods:
- Substudy of the SAKURA AF Registry, a Japanese multicenter observational study.
- Median follow-up of 39 months.
- Creatinine clearance (CrCl) estimated by Cockcroft-Gault formula, categorized into normal (≥80 mL/min), mild (50-79 mL/min), and moderate-severe (<50 mL/min) CKD.
Main Results:
- Data from 3242 patients (52% DOAC, 48% warfarin users).
- Patients with CrCl < 50 mL/min had significantly higher risks of death (HR 2.53), cardiovascular events (HR 2.53), strokes (HR 2.13), and major bleeding (HR 1.83) compared to CrCl ≥ 80 mL/min.
- No statistically significant difference in adverse event risks between DOACs and warfarin users within each renal function category.
Conclusions:
- Moderate-severe CKD is linked to increased mortality, cardiovascular events, strokes, and major bleeding.
- DOACs and warfarin demonstrate comparable safety and effectiveness across various renal function levels in Japanese AF patients.
- Worsening renal function elevates the incidence of adverse events, particularly death and cardiovascular events.
Background:
Atrial fibrillation (AF) and chronic kidney disease (CKD) often coexist, but the real-world data after approval of direct oral anticoagulants (DOACs) are still lacking in Japan. We investigated the association of the baseline renal function and adverse clinical events and risk of adverse clinical events with DOACs compared to warfarin for each renal functional level in Japanese AF patients.
Methods:
The present substudy was based on the SAKURA AF Registry, a Japanese multicenter observational registry (median follow-up period: 39 months). The creatinine clearance (CrCl) values were estimated by the Cockcroft-Gault formula, and divided into normal renal function, and mild and moderate-severe CKD (CrCl ≥ 80, 50-79, <50 mL/min).
Results:
In the SAKURA AF Registry, the baseline CrCl data were available for 3242 patients (52% for DOAC and 48% for warfarin user). The relative risk of adverse clinical events was significantly higher in the patients with a CrCl < 50 mL/min as compared to those with a CrCl ≥ 80 mL/min (adjusted HRs: 2.53 for death, 2.53 for cardiovascular [CV] events, 2.13 for strokes, and 1.83 for major bleeding). Risks of all adverse clinical events were statistically even between DOAC and warfarin users for each renal function level.
Conclusion:
Moderate-severe CKD was associated with a higher mortality, CV events, strokes, and major bleeding than normal renal function. The safety and effectiveness of DOACs over warfarin were similar for each renal function level. By a worsening renal function, the incidence of adverse clinical events increased, especially deaths and CV events as compared to strokes and major bleeding.
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